MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK FEMORAL TRIAL

Catalog Number UNK FEMORAL TRIAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Limb Fracture (4518)

Event Date 01/20/2021

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed abdel mp, wyles cc, viste a, perry ki, trousdale rt, berry dj.Extended trochanteric osteotomy in revision total hip arthroplasty: contemporary outcomes of 612 hips.J bone joint surg am.2021 jan 20;103(2):162-173.Doi: 10.2106/jbjs.20.00215.Pmid: 33252587.Objective and methods: the goals of the current study were to assess the union rate, complications, and outcomes of contemporary extended trochanteric osteotomies (etos) performed during revision thas at a single institution between 2003-2013.A retrospective review of 612 etos performed during revision of unknown devices were included in the study.The revised devices, as well as the newly implanted acetabular components are unknown.The study indicates that 265 competitor segmented stems, 134 competitor modular restoration stems, 69 uncemented unknown stems, and 144 depuy solution stems were utilized in the reconstruction.The manufacturer of the femoral heads was not specified.The manufacturer of the cables utilized to secure the revision stem are unknown.The authors concluded the use of etos shows that the union rate is high and clinically important trochanteric migration is infrequent.The most common complications are fracture of the osteotomy fragment intraoperatively or postoperatively.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: depuy solutions femoral stem, solutions femoral broach, solutions femoral stem trial, solutions femoral reamer, unknown femoral head this complaint will capture all events potentially associated with the depuy devices.Results associated with the competitor implants will be excluded.The femoral heads utilized with the stems are unknown.It is reasonable to assume that a depuy femoral head was paired with the depuy solutions stem, though this is not confirmed.The acetabular components utilized in this study are unknown.Adverse event(s) and provided interventions possibly associated with depuy devices: as there is insufficient information provided to capture the actual devices revised, this complaint will capture all of the following events with the quantity of 1.Revisions: aseptic loosening of the stem, stem fracture, periprosthetic joint infection (stem and head), leg length discrepancy (stem and head),and dislocation (head).Intraoperative femoral fractures treated with cabling: femoral fracture while trialing/reducing the femoral stem, femoral fracture while reaming the femur, femoral fracture while broaching,and femoral fracture during stem implantation.Reoperations: unspecified surgical procedure to address non-union of an osteotomy site, irrigation and debridement to treat infection, and removal of unspecified hardware.Post-operative complications: infection- treatment unspecified, dislocation: treatment unspecified,and periprosthetic femoral fracture: treatment unspecified.Radiographic findings: migration of the femoral stem.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK FEMORAL TRIAL
• Type of Device: UNK FEMORAL TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 13978799
• MDR Text Key: 288400459
• Report Number: 1818910-2022-05987
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK FEMORAL TRIAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 04/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK BROACH; UNK HIP FEMORAL STEM SOLUTION; UNK REAMER; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention